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A study to examine the effectiveness of a multilevel Community Health Workers intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos in Miami.

Condition or disease

Intervention/treatment

Phase

DiabetesHeart DiseaseHypertension

Behavioral: CARIÑO Project

Not Applicable

Detailed Description:

Disparities in the epidemiology of cardiovascular disease (CVD) risk factors among Latinos have been extensively described; however, traditional medical models of CVD risk reduction have not been very effective in Latinos. One promising strategy is the use of community-based community health workers (CHWs). CHWs have long been used in Latin-America as an integral part of their health care delivery system. Further, preliminary data from our prior pilot diabetes self-management CHW program have shown improvements in lipids. However, because of a lack of effectiveness data from studies using rigorous experimental designs, the adoption of the CHW model has been quite limited both locally and nationally. In MHHI, our goal is to examine the effectiveness of a CHW intervention in CVD risk reduction among Latinos.

We propose to examine the effectiveness of a multilevel CHW intervention as an adjunct to routine primary care in reducing CVD risk factors among diabetic Latinos Miami. The UM Jay Weiss Center which has substantial experience in Community Health Worker Program will take the lead role in the development and implementation intervention of the CHW program.

Primary Objective: To determine if the CHW intervention results in lowering of CVD risk factors including blood pressure, LDL cholesterol, and diabetes control (AIC) as measured by the Total Framingham Risk Score (FRS).

Secondary Objectives: To determine if the CHW intervention results in improvements in the following putative mechanisms that may influence the FRS:

Medication adherence (measured by validated instruments)

Improvements in diet and exercise (as measured by validated instruments);

Hypotheses: Among patients receiving care at the ACC we hypothesize that as compared to those in enhanced usual care, patients randomized to the CHW intervention at 18 months will have:

The CHW intervention will involve 4 or more (as required) home visits, 10 group sessions, an 10 follow-up phone calls per subject over a 12-month time period. The primary outcome is a HgA1C; secondary outcomes include LDL levels, and systolic and diastolic blood pressure. Baseline and follow-up data on medication adherence, medication intensification, diet and exercise will also be collected.

The control group will continue to receive usual care from their primary care physician. We will enhance the usual care that these patients receive by providing them with three sets of educational materials published by the NIH.

Care, Attention, Resources, Information, Nutrition and Optimism Project (CARIÑO Project) will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals.

Behavioral: CARIÑO Project

Care Attention Resources Information Nutrition & Optimism Project (CARIÑO) is a CHW intervention that will involve 4 or more (as required) home visits, 10 group sessions, and 10 follow-up phone calls per subject over a 12-month period. The primary outcome is lower HgA1C levels. The secondary outcomes are to lower LDL levels, and systolic and diastolic blood pressure, medication adherence and improved diet and exercise. CARIÑO Project will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals.

To determine if the Community Health Worker intervention results in lowering of CVD risk factors including blood pressure, cholesterol, and diabetes (A1C) measured by the Total Framingham Risk Score (FRS). [ Time Frame: Participants will be followed for the duration of 12 months. ]

Secondary Outcome Measures :

To determine if the Community Health Worker intervention results in improvements in the following putative mechanisms that may influence the FRS: Medication adherence and improvements in diet and exercise. [ Time Frame: Participants will be followed for the duration of 12 months ]

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Ages Eligible for Study:

35 Years to 70 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Adult patients age 35-70 years

Receiving care at ACC clinic (2 visits with a primary care provider in the previous year)

Living in Miami-Dade county (based on zip codes)

Had a hemoglobin A1C done within the past year, with the latest value being >=8.0